FlipTubes Instructions for Use (IFU)
Intended Use:
Hamilton FlipTubes are specimen receptacles specifically intended for the collection, containment, preservation, and automated handling of specimens, such as tissue, blood, saliva, or urine, for the purpose of in-vitro diagnostics or in-vitro examination, e.g., forensic, genomic, clinical research, food testing. The specimen receptacles are designed to facilitate automated sample preparation for subsequent analysis. They are intended to be used in combination with Hamilton automated liquid handling robots Microlab STAR and Microlab VANTAGE, ensuring a fully automated workflow for specimen processing prior to subsequent analysis.
You can download the Instructions for Use (IFU) in multiple languages above. Additional languages are available upon request.
Transport and Storage
The Hamilton FlipTubes are packaged in a sealed bag and packed in a cardboard box. They are therefore protected against moisture and transport damage.
- Transport: The product must be transported at temperatures between -15 °C (+5 °F) and +55 °C (+131°F) up to a maximum of 90 days. This is indicated on the secondary label (cardboard box).
- Storage: The product must be stored at temperatures between 0 °C (+32 °F) to +35 °C (+95 °F) until expiration. This is indicated on the primary label (bag)
- Short-term temperature peaks: Up to +55 °C (+131°F) for a maximum of 90 days and storage up to +45°C (+113 °F) for up to one year at any point during the product shelf-life period are validated and do not affect product integrity.
- Relative Humidity: Not required.
Purity Grade
The FlipTubes are produced in a Cleanroom (ISO Class 8) and are free of Pyrogens, RNAse, DNAse, PCR Inhibitors,
Human DNA, and ATP. With the packaging format described above, it is ensured that the FlipTubes maintain their Purity Grade status during both transport and storage. Hamilton FlipTubes are available as both sterile and non-sterile products.
Sterility
The FlipTubes are treated with ethylene oxide (EO). This is indicated on the primary and secondary label. On the secondary label is an indicator which turns green after treatment.
Shelf Life
The FlipTubes have a shelf of 5 years, after the date of production. The shelf life is indicated on the primary and secondary label. After opening the sealed bag, the shelf life remains unchanged, but the purity of the product can no longer be guaranteed. It is recommended to perform a visual inspection for damage to packaging prior to use and to open the sealed bag just before use.
Disposal
TheFlipTubes Tubes are intended for single use
Legal Aspects
Hamilton Company and Hamilton Bonaduz AG are the Legal Manufacturers of the FlipTubes,
all rights reserved.
This Instructions for Use (IFU) document may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Company or Hamilton Bonaduz AG.
Note
Any serious incident or near-incident that has occurred in relation to the consumables shall be reported to Hamilton and to the competent authority of the Member State in which the operator is established.
Contact Hamilton either by contacting a local Hamilton representative or by utilizing Hamilton’s webpage, which can be found on the footer of this document.
If you have questions on our other consumable products, such as: reservoirs, plates, tubes, sealing consumables, and waste consumables, please visit our website under this link:
https://www.hamiltoncompany.com/consumables-labware-accessories
Symbols on the Label
